Events

Recall of DATEX-OHMEDA NELLCOR COMPATIBLE OXYGEN SATURATION MODULE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DATEX-OHMEDA (CANADA) INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75383
  • Event Risk Class
    II
  • Event Initiated Date
    2001-02-12
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Risk of spo2 value freezing permanently on the monitor display when used in combination with b-int interface board or m-int interface module if a temporary break in communication to m-int or b-int.

Device

DATEX-OHMEDA NELLCOR COMPATIBLE OXYGEN SATURATION MODULE
  • Model / Serial
    Model Catalog: M-NSAT (Lot serial: S/NS: 3570995 3570988); Model Catalog: M-NSAT (Lot serial: 3570990 3586769 3586768); Model Catalog: M-NSAT (Lot serial: 285390 285391 286158.); Model Catalog: M-NSAT (Lot serial: 285386 285387 D-285389); Model Catalog: M-NSAT (Lot serial: 285383 285384 285385); Model Catalog: M-NSAT (Lot serial: D-286453 285373 285382); Model Catalog: M-NSAT (Lot serial: D-286448 D-286449 D-286450); Model Catalog: M-NSAT (Lot serial: D-286442 D-286444 D-286447); Model Catalog: M-NSAT (Lot serial: D-286437 D-286440 D-286441); Model Catalog: M-NSAT (Lot serial: D-286218 286221 D-286436); Model Catalog: M-NSAT (Lot serial: D-286215 D-286216 D-286217); Model Catalog: M-NSAT (Lot serial: D-286211 286213 D-286214); Model Catalog: M-NSAT (Lot serial: 286208 D-286209 D-286210); Model Catalog: M-NSAT (Lot serial: 286204 286205 D-286207); Model Catalog: M-NSAT (Lot serial: D-286191 D-286196 D-286201); Model Catalog: M-NSAT (Lot serial: 286029 D-286170 286182); Model Catalog: M-NSAT (Lot serial: 28588
  • Product Description
    NELLCOR COMPATIBLE OXYGEN SATURATION MO
  • Manufacturer
    DATEX-OHMEDA (CANADA) INC.

Manufacturer

DATEX-OHMEDA (CANADA) INC.
  • Manufacturer Address
    MISSISSAUGA
  • Source
    HC